68Ga-DOTA-Bombesin PET/MRI in Imaging Patients With Prostate Cancer

Prostate Carcinoma Clinical Trial

Official title:

68Ga-DOTA-Bombesin PET/MRI in the Evaluation of Patients With Prostate Cancer: A Feasibility Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02440308
• Other study ID #: PROS0069
• Secondary ID: NCI-2015-00673PR
• Status: Active, not recruiting
• Phase: N/A
• First received: May 1, 2015
• Last updated: June 22, 2016
• Start date: April 2015
• Est. completion date: December 2016

Study information

• Verified date: June 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This clinical trial studies the use of gallium-68 (68Ga)-DOTA-Bombesin positron emission tomography (PET)/magnetic resonance imaging (MRI) in imaging patients with prostate cancer. PET uses a radioactive substance called 68Ga-DOTA-Bombesin, which attaches to tumor cells with specific receptors on their surfaces. The PET scanner takes pictures that capture where the radioactive drug is "lighting up" and attaching to tumor cells, which may help doctors recognize differences between tumor and healthy prostate tissue. MRI uses radio waves and a magnet to make a picture of areas inside the body. Using 68Ga-DOTA-Bombesin in diagnostic procedures, such as PET/MRI, may allow doctors to identify smaller tumors than standard imaging.

Description:

PRIMARY OBJECTIVES:

I. To evaluate the feasibility and biodistribution of 68Ga-DOTA-Bombesin (BAY 86-7548 or 68Ga-DOTA RM2).

OUTLINE:

Patients receive 68Ga-DOTA-Bombesin intravenously (IV) and then undergo PET/MRI approximately 60 later.

After completion of study, patients are followed up at 24 hours and 1 week.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Provides written informed consent

• Known diagnosis of prostate cancer

• Patient has suspected recurrence based on biochemical data (prostate-specific antigen [PSA] > 2 ng/mL)

• Able to remain still for duration of each imaging procedure (about one hour)

Exclusion Criteria:

• Unable to provide informed consent

• Inability to lie still for the entire imaging time

• Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)

• Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance

• Metallic implants

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Carcinoma
• Prostatic Neoplasms

Intervention

Radiation:
• Gallium Ga 68-labeled GRPR Antagonist BAY86-7548
Receive 68Ga-DOTA-Bombesin IV

Procedure:
• Magnetic Resonance Imaging
Undergo 68Ga-DOTA-Bombesin PET/MRI
• Positron Emission Tomography
Undergo 68Ga-DOTA-Baombesin PET/MRI

Locations

Country	Name	City	State
United States	Stanford University Hospitals and Clinics	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biodistribution of 68Ga-DOTA-Bombesin	Uptake in various normal organs will be evaluated visually and measured semi-quantitatively in patients with prostate cancer. Uptake values in different tissues will be measured (mean/standard deviations) using AW workstations.	At time of imaging (1 hour)	No
Primary	Feasibility, determined by the number of participants to complete the examination	The number of participants to complete the examination will be evaluated and compared with similar patient group enrolled in other PET/MRI studies.	Up to 1 week	No